Banophen™

Manufacturer
Major Pharmaceuticals
Effective date
2026-09-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-17 02:02:09

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Dosage and administration

• take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years of age and older  1 to 2 capsules children 6 to under 12 years of age   1 capsule children under 6 years of age   do not use

Storage and handling

• store at 20–25°C (68–77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Warnings

WARNINGS SECTION

Do not use • to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis
• glaucoma • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
• marked drowsiness may occur • avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours

adults and children 12 years of age
and older
 1 to 2 capsules
children 6 to under 12 years of age  1 capsule
children under 6 years of age  do not use

Other information

STORAGE AND HANDLING SECTION

• store at 20–25°C (68–77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, corn starch, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

MAJOR®

compare to the active ingredient in Benadryl® Allergy*

Banophen™

diphenhydramine HCl, 25 mg

antihistamine
allergy relief of:
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat

NDC 0904-7672-24
24 capsules

NDC 0904-7672-61
100 capsules
(10x10) unit dose

NDC 0904-7672-60
100 capsules

NDC 0904-7672-80
1000 capsules

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Made in India

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Benadryl®.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Rev. 04/26 M-173 Re-order No. 701464
CT0904767224 REV.00-042026

Rev. 04/26 M-173 Re-order No. 701467
CT0904767261 REV.00-042026

Rev. 04/26 M-173 Re-order No.701465
REV.00-042026 LB0904767260

Rev. 04/26 M-173 Re-order No. 701466
LB0904767280 REV.00-042026

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Banophentm-1Banophentm-1

Banophentm-2Banophentm-2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-76720904-7672-24, 0904-7672-61, 0904-7672-60, 0904-7672-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9713d8ee-6ab2-2fdf-e053-2a95a90a9e192026-08-19Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCLDIPHENHYDRAMINE HYDROCHLORIDERedmont Pharmaceuticals, LLCd8944f3c-acef-4ebe-9633-7d641ae95edf2026-08-03Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.